BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    Excella Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    ZESPIN SI Joint Fusion System

    FDA UDI
    Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm

    Universal Ryno Lacer Wrist and Thumb Support

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357235117·

    NA

    FDA UDI
    Synthes GmbH·10886982157737·3.5MM MEDIAL DISTAL TIBIA PLATE 10 HOLES/147MM-...

    S9 VPAP TX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANCED PATELLA 26MM 3 PEG IMPLANT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 8, 2023

    CANNULATED SCREW, 3.5 MM SELF DRILLING/TAPPING

    FDA Adverse Event
    Injury ·PIONEER SURGICAL·Product code OUR·October 29, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    2520274-2013-04200

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·July 12, 2013

    Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026